Anastomosis device and method

ABSTRACT

Methods and surgical devices for performing an anastomosis of a living tissue. More particularly the methods and devices relate to anastomosis of tissue performed through tissue fusion performed by delivering energy to the tissue.

RELATED APPLICATIONS

This application is a non-provisional of U.S. Provisional applicationNos. 62/838,694 filed Apr. 25, 2019 and 62/845,449 filed May 5, 2019each of which are incorporated by reference. This application is alsorelated to PCT application PCT/US2020/030039 filed Apr. 27, 2020, theentirety of which is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to methods and surgical devices forperforming an anastomosis of a living tissue. More particularly themethods and devices relate to anastomosis of tissue performed throughtissue fusion performed by delivering energy to the tissue.

BACKGROUND OF THE INVENTION

Most traditional techniques for mechanically performing anastomosis ofhollow organs involve the use of mechanical staplers that connect tissueedges of the dissected hollow organ by inserting metallic or plasticstaples into the tissue. The need to perform anastomosis of tubularbodies can be found in gastric, esophageal, intestinal surgery andespecially in vascular procedures. End to end anastomoses are generallyperformed by surgical staplers that deliver pairs of staggered rings ofstaples. The traditional process can also involve cutting the tissuewith a circular knife blade to separate the tissue that is held withinthe circular ring. The separated tissue is then removed with the staplerto form a circular opening within the lumen along the stapling line.

In contrast to suturing tissue, electrosurgical tissue fusion can beused to join tissue without conventional sutures or in addition tosuturing. The present disclosure includes methods and devices forperforming an anastomosis using electrosurgical tissue fusion.

SUMMARY OF THE INVENTION

The present disclosure includes methods and devices for performingtissue fusion. The methods and devices can be suited for performingend-to-end anastomosis. In one example of such a device, the deviceincludes an elongate shaft carrying a first clamping component and asecond clamping component each respectively having a firsttissue-engaging face and a second tissue-engaging face, the firsttissue-engaging face and the second tissue-engaging face configured forclamping together a first end of a first tubular organ segment and asecond end of a second tubular organ segment; a circular bi-polarelectrode arrangement in at least of the first tissue-engaging face andthe second tissue-engaging face, the circular bi-polar electrodearrangement configured to deliver energy from the energy source tothermally join the first end to the second end; and at least on aperturein at least one of the first tissue-engaging face and the secondtissue-engaging face communicating with a flow channel in the shaft forproviding inflows or outflow.

A variation of the device can further include a fluid source configuredto provide fluid inflows through the flow channel and apertures todeliver fluid which facilitates release of welded tissue from the firsttissue-engaging face and the second tissue-engaging face. The aperturescan be disposed in both of the first tissue-engaging face and the secondtissue-engaging face or only in one tissue engaging face.

In another variation, the surgical device includes a bi-polar electrodearrangement carried in both of the first tissue-engaging face and thesecond tissue-engaging face. The bi-polar electrode arrangement cancomprise a plurality of spaced apart circular electrodes of opposingpolarities.

The devices described herein can include an energy supply that comprisesa controller and at least one electrical source for delivering currentand where the bi-polar electrode arrangement is operatively connected tothe controller and the at least one electrical source.

The controller can be adapted to sense at least one electrical parameterof current delivery consisting of impedance, capacitance and/or phaseangle to sense the thickness of engaged tissue when the first and secondclamping components engage tissue. In another variation, the controlleris adapted to multiplex current delivery among various pairs of opposingpolarity electrodes. The controller can be adapted to modulate currentdelivery to the bi-polar electrode arrangement in response to signalsfrom at least one temperature sensor. Alternatively, controller can beadapted to sense at least one electrical parameter of current deliveryconsisting of impedance, capacitance and/or phase angle to sense aneffective tissue weld. The controller can also terminate currentdelivery when a sensed electrical parameter indicates said effectivetissue weld. Additional variations of the controller are adapted todeliver the fluid inflows from the fluid source after sensing aneffective tissue weld. The controllers can deliver the fluid inflows foran interval ranging from 1 second to 60 seconds.

In another variation of the device, the device includes a motor driveconfigured to move the first clamping component and the second clampingcomponent. The controller can be adapted to actuate the motor drive tomove the first clamping component and the second clamping component at avariable rate. In additional variations, the controller is adapted toactuate the motor drive to move the first clamping component and thesecond clamping component at a first closing rate until the firstclamping component and the second clamping component are spaced apart bya selected distance followed by a second closing rate to compress atissue between the first clamping component and the second clampingcomponent to a thickness of less than 0.5 mm (or any otherrange/distance as required). The controller can also stop the movementtogether of the first clamping component and the second clampingcomponent when the thickness of the engaged tissue is within apreselected range. Additionally, or in the alternative, the controllerstops the movement together of the first clamping component and thesecond clamping component controller when the controller senses at leastone electrical parameter indicates the thickness of the tissue is withina preselected range. The controller can also actuate the motor drive tomove apart the first clamping component and the second clampingcomponent after the controller senses at least one electrical parameterindicating an effective tissue weld.

In an additional variation, the controller is adapted to actuate themotor drive to move apart the first clamping component and the secondclamping component after a predetermined interval of delivering fluidinflows from the fluid source.

Controllers for use with the devices described herein can be adapted toactuate the motor drive to move apart the first clamping component andthe second clamping component at variable speeds. Furthermore, thecontroller can be adapted slow or stop actuation of the motor drive tomove apart the first clamping component and the second clampingcomponent when the controller senses resistance to moving apart cause bytissue adhering to the bi-polar electrode arrangement. In an additionalvariation, the controller can be adapted to sense resistance movingapart the first clamping component and the second clamping component bysensing motor voltage. An additional variation of the controller allowsfor actuating the motor drive to move a circular cutting member axiallyfrom either the first clamping component and the second clampingcomponent to excise tissue inwardly of the first tissue-engaging faceand the second tissue-engaging face. The controller can also be adaptedto actuate the motor drive to move the circular cutting member after thecontroller senses at least one electrical parameter that indicates aneffective tissue weld.

Another variation of a surgical device for end-to-end anastomosis caninclude an elongate shaft carrying a first clamping component and asecond clamping component each respectively having a firsttissue-engaging face and a second tissue-engaging face, the firsttissue-engaging face and the second tissue-engaging face configured forclamping together a first end of a first tubular organ segment and asecond end of a second tubular organ segment; a circular bi-polarelectrode arrangement in at least of the first tissue-engaging face andthe second tissue-engaging face, the circular bi-polar electrodearrangement configured to deliver energy from the energy source tothermally join the first end to the second end; and wherein the firsttissue-engaging face and the second tissue-engaging face are orientedrelative to the central axis at an angle ranging from 30° to 85°.

In an additional variation, a surgical device for an end-to-endanastomosis of tubular organ segments includes an elongate member havinga central axis carrying a first clamping component having a firsttissue-engaging face; a second clamping component having a central shaftadapted for lockable coupling to the first clamping component, andhaving a second tissue-engaging face; an actuator mechanism coupled tothe first clamping component and the second clamping component andconfigured to move the first clamping component and the second clampingcomponent together so that the first tissue engaging face and the secondtissue-engaging face clamp together respective ends of the tubular organsegments; electrodes in both the first tissue engaging face and thesecond tissue-engaging face; and at least one aperture in the firsttissue engaging face and in the second tissue-engaging facecommunicating with a remote fluid source.

The fluid source can be configured to cause pulsed inflows through theat least one aperture. Alternatively, or in combination, the fluidsource can be configured to cause non-pulsed inflows through the atleast one aperture.

Variations of the device include the second clamping component having aflow pathway extending from the at least one aperture therein to aproximal end of the central shaft. In addition, a proximal end of thecentral shaft can include a connector for fluid-tight connection of theflow pathway to a flow channel in the elongate member that communicateswith the fluid source. The second clamping component can include anelectrical conductor extending from an electrode therein to a proximalend of the central shaft. The central shaft can also include a connectorfor coupling the electrical conductor with a cooperating electricalconductor in the elongate member that is adapted for connection to anelectrical source. In an additional variation, the second clampingcomponent includes a bore for receiving the central shaft, furtherincluding at least one sealing element for providing a fluid tight sealbetween the central shaft and the bore. The central shaft and bore canbe configured with a key for causing the central shaft to be oriented ina selected rotational position when being coupled with the bore.

The present disclosure also includes a variation of a surgical devicefor end-to-end anastomosis comprising: an elongate shaft carrying afirst clamping component and a second clamping component eachrespectively having a first tissue-engaging face and a secondtissue-engaging face, the first tissue-engaging face and the secondtissue-engaging face configured for clamping together a first end of afirst tubular organ segment and a second end of a second tubular organsegment; a first electrode the first tissue-engaging face and a secondelectrode in the second tissue-engaging face, the first and the secondelectrode configured to deliver energy from an energy source tothermally join the first end to the second end; and a plurality ofinsulative projecting elements in at least one tissue-engaging facefigure to prevent contact of an electrode in the first face with anelectrode in the second face as the clamping components areapproximated.

In another variation, the present disclosure includes methods of usingan electrosurgical device for connecting tubular organ segments so as tocommunicate with one another. For example, such a method can includepositioning the walls of a first tubular organ segment around a proximalface of a first clamp component of the device; positioning the walls ofa second tubular organ segment around a distal face of a second clampcomponent of the device; moving together the first and second clampingcomponents thereby clamping together walls of the first and secondtubular organ segments; and delivering electrosurgical energy betweenthe proximal and distal faces of the clamping components to therebyprovide a circular thermal weld in the walls to connect the tubularorgan segments.

The method can also include multiplexing energy delivery between aplurality of pairs of opposing polarity electrodes in the proximal anddistal faces.

A variation of the method further comprises removing steam from theenergy delivery site through a flow pathway in the device. The steam canescape passively through the flow pathway. Alternatively, or incombination, the steam can be extracted by a negative pressure source.

The method can also include excising tissue inwardly of the proximal anddistal faces to thereby connect the lumens of the first and secondtubular organ segments. Excising can be performed with a blade or anelectrosurgical cutting element.

Another variation of a method of using an electro surgical device forconnecting tubular organ segments so as to communicate with one another,includes positioning the walls of a first tubular organ segment aroundan electrode-carrying face of a first clamp component, wherein the faceis coated with a biocompatible fluid for preventing tissue adherencethereto; positioning the walls of a second tubular organ segment aroundan electrode carrying face of a second clamp component, wherein the faceis coated with a biocompatible fluid for preventing tissue adherencethereto; moving together the first and second clamping componentsthereby clamping together walls of the first and second tubular organsegments; and delivering electrosurgical energy between the proximal anddistal faces of the clamping components to thereby provide a circularthermal weld in the walls to connect the tubular organ segments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a surgical instrument corresponding to theinvention illustrating a general overall view of the instrument.

FIG. 2 is a perspective and cut-away view of the working end of theinstrument of FIG. 1 showing the proximal and distal tissue engagingfaces in a bi-polar electrode arrangement.

FIG. 3A is an enlarged sectional view taken line 3A-3A of FIG. 2 showinga portion of the bi-polar electrode arrangement of FIG. 1 and alsoshowing multiplexed RF current delivery between adjacent pairs ofelectrodes.

FIG. 3B is another view of the bi-polar electrode arrangement of FIG. 3Ashowing multiplexed RF current delivery between different pairs ofadjacent electrodes.

FIG. 3C is yet another view of the bi-polar electrode arrangement ofFIGS. 3A-3B showing multiplexed RF current delivery between pairs ofnon-adjacent electrodes.

FIG. 4 is a perspective and cut-away view of another working end of aninstrument similar to that of FIG. 2 illustrating a different variationof a bi-polar electrode arrangement.

FIG. 5 is a sectional view of another bi-polar electrode arrangementsimilar to that of FIG. 3A illustrating ring electrodes with a smoothprojecting surface for extracting tissue.

FIG. 6A is a view of the bi-polar electrode of FIG. 3A with a distalopposing face comprising flexing member that is adapted to progressivelyengage and compress tissue, with a flex member is shown initiallyengaging tissue at an outer periphery of the working end.

FIG. 6B is a view of the bi-polar electrode of FIG. 6A showing theflexing member progressively engaging tissue towards the center of theworking end.

FIG. 7A illustrates a method of the invention for welding together toorgan segments wherein an initial step includes positioning proximalclamp assembly in a first organ segment and a distal clamp assembly in asecond organ segment.

FIG. 7B illustrates a subsequent step of the method wherein the distalclamp assembly is latched into the proximal clamp assembly.

FIG. 7C illustrates a subsequent step wherein a lever arm in the handleis actuated to move the distal clamp assembly toward the proximal clampassembly to engage tissue and wherein the flexing member of the distalclamp assembly progressively engages tissue.

FIG. 7D illustrates a subsequent step wherein the lever arm in thehandle is further actuated to cause the clamp assemblies toprogressively engage tissue, followed by RF energy being delivered toweld together the organ segments, followed by actuating the cuttingblade to cut and removed the tissue between the lumens of the organsegments.

FIG. 7E illustrates a final step wherein the lever arm in the handle isactuated to release the clamping forces to disengage tissue andthereafter removal of the working end in the proximal direction.

FIG. 8 is a perspective and schematic view of another clamp assembly ofan instrument similar to that of FIGS. 2 and 4 illustrating pressuresensors that are configured to measure and signal tension on organsegments that are intended to be clamped together wherein in asignificant tension is undesirable.

FIG. 9 illustrates another step of a method of the invention whichcomprises measuring the actual tension on the organ segments aftercoupling of the proximal and distal clamp assemblies.

FIG. 10 is a side view of another variation of a surgical instrumentsimilar to that of FIG. 1 except the device is motor driven to close theclamp assemblies.

FIG. 11 is a perspective cutaway view of an alternative distal clampassembly similar to that of FIG. 2 except new variation carries anelectrode array as well as fluid flow channels similar to those featuresas described in FIG. 2-6B in the proximal clamp assembly.

FIG. 12 is a perspective and schematic view of another clamp assembly ofan instrument similar to that of FIGS. 2 and 4 illustrating a coolingmechanism in the clamp assembly for cooling tissues to thereby preventdamage to tissues outside of the targeted welding zone.

FIG. 13 is a diagram illustrating the steps of a method corresponding tothe invention to determine the thickness of engaged tissue and tothereafter thermally weld together tubular organ segments.

FIG. 14 is a diagram illustrating the steps of a method corresponding tothe invention to determine axial tension on organ segments and tothereafter thermally weld together the tubular organ segments.

FIG. 15 is a schematic view of a collagen member that can be disposedbetween surfaces of organ segments to assist in a thermal tissue weld.

FIG. 16 is a cut-away view of the working end of another variation of asurgical instrument similar to that of FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a circular anastomosis device 100 corresponding tothe invention which is adapted for end-to-end connection of two segmentsof a hollow tubular body organ (e.g., two intestinal segments). Ingeneral, the anastomosis device 100 utilizes a clamping assembly and abi-polar electrode arrangement adapted to create a circular thermal weldwhich surrounds a lumen or passageway between the connected organsegments. The device 100 further includes a circular knife for trimmingexcess tissue to connect and open the lumens of the two organ segments.

As can be seen in FIG. 1, the elongated anastomosis device 100 extendsabout a longitudinal axis 102 and includes an actuator handle portion104, a longitudinal shaft assembly 105 and a working end consisting of adistal tissue-engaging assembly 110 which captures and clamps togethertissue. The distal tissue-engaging assembly 110 or working end isfurther configured to apply energy from bi-polar electrode arrangementfor thermally welding the tissue. The longitudinal shaft assembly 105can have any suitable length and have a straight configuration, a curvedconfiguration or can consist of a flexible shaft.

Referring to FIGS. 1 and 2, the distal tissue-engaging assembly 110includes a proximal head or clamp assembly 115A and a mating distal heador clamp assembly 115B. The proximal clamp assembly 115A has a firsttissue-engaging face 120A that faces distally and carries a bi-polarelectrode arrangement 125 described in more detail below. The distalclamp assembly 115B has a second tissue engaging face 120B that facesproximally and opposes the bi-polar electrode arrangement 125. The firstand second faces 120A and 120B are adapted to capture and engage tissueunder very high compression forces as the proximal and distal clampassemblies 115A and 115B are latched together and move toward oneanother.

In FIG. 1, it can be seen that the distal clamp assembly 115B has aproximally facing central trocar shaft 140 with an optional pointedtrocar tip 142 which is adapted to longitudinally slide into a receivingchannel 144 in a hollow support tube 145 carried in the proximal clampassembly 115A. The distal clamp assembly 115B comprises an independent,detached component that is configured for placement in a tubular organsegment as is known in the art and will be described further below. Thetrocar shaft 140 includes an annular notch 148 which is engaged byopposing deflectable, spring-like retainer clips 150 carried at thedistal end of the hollow support tube 145. The retainer clips 150 engageand latch into the annular notch 148 after the trocar shaft 140 isguided into the hollow support tube 140. To facilitate insertion of thetrocar 140 into the channel 144, the trocar tip 142 has a low forceprofile which is provided by a taper at a selected angle to reduce theforce required to bias open the retainer clips 150 (see FIG. 2). Forexample, the trocar tip 142 is configured with a conical shape tofacilitate its insertion between the retainer clips 150. Such latchingmeans are known in the art of circular anastomotic staplers and need notbe described further here. Conventional circular anastomotic staplerswith similar latching features include the following: U.S. Pat. Nos.7,776,060; 5,350,104; 8,770,460; 5,222,963; 5,309,927 and 6,050,472.

As can be understood from FIGS. 1 and 2, the hollow tube 145 afterlatching to the trocar shaft 140 is configured for longitudinal movementto clamp together the first and second clamp assemblies 115A and 115B ofthe working end. As can be best seen in FIG. 1, the proximal handleportion 104 includes an actuator lever 155 adapted to move betweenpositions A, B and C to actuate components of the working end of thedevice. In one variation, the lever 155 it is pivotally mounted by meansof a pin 156 where movement of the lever from position A to position Bmoves the support tube 145, trocar 140 and the distal clamp assembly115B in the proximal direction toward the proximal clamp assembly 115A.As can be understood from FIG. 2, movement of the support tube 145 inthe proximal direction thereby moves the first and secondtissue-engaging faces 120A and 120B toward one another to engage andcompress tissue.

In one variation, a rotatable adjusting knob or grip 160 is provided atthe proximal end of the handle assembly 104 that allows for additionaladjustment of the spacing between the first and second tissue-engagingfaces 120A and 120B. Thus, the movement of the lever 155 from position Ato position B moves the clamp assemblies to clamp tissue and therotatable knob or grip 160 allows for fine adjustment of thickness oftissue after being clamped together.

The gap between the tissue-engaging faces 120A and 120B (which isequivalent to engaged tissue thickness) is shown by a tissue thicknessor gap indicator 170 in a window 172 in the handle portion 104. In onevariation, the clamp assemblies are configured to compress the engagedtissue between the tissue-engaging faces 120A and 120B to a thicknessranging from 1.0 mm or a little as 0.2 mm.

Referring to FIG. 1, a lock button 175 is provided on the handle portion104 for lock-release of lever 155 to allow its release to from positionA to position B and thereafter from position B to position C. Movementof the lever 155 from position B to position C is adapted to advance acircular cutting blade 180 distally as will the described further below.

Now referring to FIG. 2, it can be seen that the bi-polar electrodearrangement 125 comprises a plurality of ring electrodes of opposingpolarities that are adapted to deliver energy to tissue. As can be seenin FIGS. 3A-3C, the electrodes are disposed in a insulator substrate185, which can be a ceramic, glass, the polymer or any combinationthereof. In one variation, the electrodes can be a conductive metalcarried in a flex circuit material which typically is Kapton® or asimilar polymer. In another variation, conductive electrode rings can becarried in a silicone substrate.

In one variation, the number such ring electrodes can range from onepair of bi-polar electrodes to as many as 10 pairs of such bi-polarelectrodes. Referring now to FIG. 3A, one side of the first tissueengaging face 120A is shown with six ring electrodes 186 a-186 f. Eachring electrode has a selected width W that cooperates with spacing Sbetween such ring electrodes wherein the electrode width W and spacing Sare important for delivering energy to tissue uniformly to therebycreate an effective thermal weld. In general, the width W of an exposedelectrode surface ranges between 0.1 mm and 2.0 mm and the spacing Sbetween the ring electrodes ranges between 0.2 mm in 2.0 mm. As canfurther be seen in FIG. 2, the electrodes 186 a-186 f are coupled byseparate electrical leads 188 a-188 f that extend through the shaftassembly 105 and handle portion 104 to an RF electrical source 190 andcontroller 195.

In general, the controller 195 is adapted to multiplex RF current flowbetween various pairs of bi-polar electrodes in a sequence. For example,in FIG. 3A, the controller 195 causes contemporaneous RF current flowthrough tissue (not shown) between electrode pair 186 a-186 b, electrodepair 186 c-186 d and electrode pair 186 e-186 f. In FIG. 3B, thecontroller 195 causes RF current to flow between electrode pair 186b-186 c and electrode pair 186 d-186 e. In FIG. 3C, the controller 195causes RF current to flow between electrode pair 186 a-186 c andelectrode pair 186 d-186 f. In general, the controller 195 can providefor RF current flows between any paired electrodes, whether adjacent ornon-adjacent.

In a first mode of operation, the controller 195 can multiplex betweenvarious pairs of electrodes in a preset sequence over a preset timeinterval. In a second mode of operation, the controller 195 can modulateenergy delivery between any various pairs of electrodes in response tooperational signals from such as impedance determined by the controller195 for from signals from temperature sensors 200 a and 200 b in theworking end of the device 100. FIG. 3A shows temperature sensors 200 aand 200 b in the tissue-engaging surface 120A intermediate the electroderings, however the temperature sensors also can be positioned beneathone or more electrodes or in the distal tissue-engaging face 120B. Whensuch temperature sensors are carried in the distal tissue-engaging face120B, the electrical connections it can be provided by cabling andelectrical connectors in the trocar 140 as can be easily understood.

While the circular bi-polar electrode arrangement 125 shown in FIG. 2 istypical, other generally circular electrode arrangements are possible.For example, FIG. 4 shows a proximal tissue-engaging face 120A′ with abi-polar electrode arrangement 125′ comprising a plurality of electrodes205 that are oriented radially relative to axis 102 of the device 100.In this variation, the controller 195 can multiplex energy deliverybetween various electrode pairs. It should be appreciated that othercircular electrode arrangements possible, such as electrode dots,serpentine electrode pairs, etc.

FIG. 5 illustrates another variation of bipolar electrode arrangement125″ wherein the opposing tissue engaging faces 120A′ and 120B′ havecooperating with undulating surfaces for compressing and stretchingtissue. In this variation, the electrode surfaces are convex the projectoutwardly from the insulator substrate 185. It should be appreciatedthat a projecting and receiving teachers in opposing clamp surfaces canbe used for stretching and compressing tissue which may assist increating an effective tissue weld.

FIGS. 2 and 3A-3C illustrates another component of the invention whichconsists of mechanisms for extracting steam from heated tissue in theinterface between the tissue-engaging faces 120A and 120B and tissue iswelded with the bi-polar electrode arrangement 125. As can be seen inFIG. 3A, fluid flow ports 208 a-208 c are provided in the face 120Aintermediate the electrodes 185 a-186 f. The ports 208 a-208 c are opento cooperating channels 218 a-218 c extending through the device whichcommunicate with a negative pressure source 220 shown schematically inFIGS. 1 and 2. The number of locations of such ports in the firsttissue-engaging face 120A can vary in number from 1 to 20 or more andcan be distributed in any suitable manner around the face 120A. As willbe described further below, the flow channels 218 a-218 c also can beused for infusing liquid from a fluid source 225 and into the tissueinterface between the clamp assemblies following a welding procedure toassist releasing tissue from the clamping mechanism. In general, theelectrodes in the proximal in distal faces 120A and 120B should comprisenon-stick materials but infused saline can be used as a precautionarymeasure to ensure that tissue does not stick to the electrodes.

Referring to FIGS. 2 and 6A-6B, another aspect of the invention is shownwherein the distal tissue-engaging face 120B comprises a flexing member240 with radially flexing surface that is adapted to progressivelyengage tissue that is clamped between the tissue-engaging faces 120A and120B. As can be seen in FIGS. 2 and 6A, the flexing member 240 cancomprise a spring-like metal form that is adapted to flex from anon-planar shape with surface angle X to a planar shape with surfaceangle Y which is perpendicular to axis 102 and parallel to the opposingproximal face 120A and the electrode arrangement 125. The function ofthe deflectable surface of the flexing member 240 is to initially engagetissue that is radially outward relative to central axis 102 of thedevice 100 and thereafter progressively compress the engaged tissue inthe radially inward direction. Such progressive engagement of tissue isuseful because the objective deliver energy to thermally weld the outerlayers of the organ wall, without interference from fatty, innersurfaces of the intestinal wall. Thus, the progressive engagement thecompression of the intestinal walls will squeeze and urge the fattytissue and elemental radially inwardly and potentially inwardly from theregion engaged by the bi-polar electrode arrangement 125. The outermembranes of the intestinal segments contain muscle tissue, connectivetissue and the like which can be welded effectively.

In FIGS. 6A-6B, it can be seen that the distal tissue-engaging face 120of the flexing member 240 is a circular surface slope at an angle X in arepose position. The circular inner edge 242 the flexing member 240 issecured to the body 245 of the distal clamp assembly 115B. The circularouter edge 250 of the flexing member 240 is adapted to movelongitudinally into the circular slot 252 as the member is flexed. Itshould be appreciated that the flexing member in this variation cancomprise a conductive metal material and can have various stent-typeperforations arranged in the flexing member 240 to accommodate itsmovement and change of its surface shape from angle X to angle Y.

FIG. 6B shows the flexing member 240 entirely compressed against tissuein the opposing proximal tissue engaging face 120A which flattens theflexing member 240 to match the plane of the surface of the electrodearrangement 125.

In another aspect of the invention referring to FIGS. 2 and 6A, avariation of the proximal clamp assembly includes a lip or projectingedge 270 at the outer periphery of the proximal tissue engaging surface120A that is adapted to overlap or engage opposing portion 272 of thedistal clamp assembly to thereby limit steam from being expelledradially outwardly from the device during energy delivery. Whendelivering energy to tissue, it can be understood that the mediandesiccation tissue can cause steam formation, it is probable that anysuch steam being captured in the tissue and not released outwardly whichcould damage the organ segment outside the weld W. It should beappreciated that other features can perform a similar purpose such asflexible seals or O-rings on one or both of the radio outward edges ofthe clamp assemblies. For example, FIG. 4 shows an exemplary proximalclamp assembly 115A′ with a flexible elastomeric seal 275 around theperimeter of the proximal tissue engaging face 120′. As another example,FIG. 5 shows cooperating elastomeric seals 277 a and 277 b in bothtissue engaging faces 120A and 120B.

In another aspect of the invention referring to FIGS. 2 and 6A, thedistal tissue-engaging face 120B comprises the flexing member 240 whichis a conductive metal such as stainless steel and the surface as apassive electrode 280. Thus, RF current flow between pairs electrodes inthe opposing proximal clamp surface 120A can be conducted through theengaged tissue and the passive electrode which may assist in creating aneffective thermal weld W (FIG. 7E). In other variations, the tissueengaging surface 120B in the distal clamp assembly 115A can comprise ina nonconductive material. For example, FIG. 8 illustrates a tissueengaging surface 120B″ that can consist of a monolithic block ofelastomeric material, such as indent silicone or similar material, thatis compressible to provide for progressive engagement above tissue asdescribed previously in FIGS. 6A and 6B.

Referring again to FIG. 2, it also can be seen that the proximal clampassembly 115A carries a circular cutting blade 180 that is adapted tomove longitudinally to cut excess tissue radially inward from thecircular electrode arrangement 125. In one variation, the circular blade180 is actuated to move in the distal direction by the actuator leverthe little left and 155 when moved from position B to position C as canbe seen in FIG. 1.

Now turning to FIGS. 7A-7E, 8 and 9, methods using the device 100 ofFIG. 1 or the device of FIG. 10 to connect tubular organ segments 400 aand 400 b is shown schematically. FIG. 10 illustrates a device 100′ thatis similar to the device of FIG. 1 except a motor 300 with actuatorbutton 320 is provided in the handle body 305 to close and open theclamp assemblies and to actuate the circular cutting blade. In thisvariation, the controller 195 can control the speed of closure which canbe responsive to sensed tissue parameters as described further below.

In a typical application of joining two intestinal segments 400 a and400 b together, the components are positioned in tissue organ segmentsas shown in FIG. 7A. The severed ends of organ segments 400 a and 400 btypically are secured with manually sewn, purse-string sutures. Theproximal clamp assembly 115A is disposed in the lumen 402 a of organsegment 400 a. The distal clamp assembly 115B is disposed inside thelumen 402 b of distal segment 400 b and the trocar 140 then extendsthrough the sutured end of the distal segment 400 b.

As can be seen in FIG. 7B, the trocar 145 is then pushed longitudinallyinto the support tube 140 of the proximal clamp assembly 115A andlatched therein as shown in FIG. 2. FIGS. 7B-7D schematically illustratethe progressive engagement of tissue by the first and second clampassemblies 115A and 115B to thereby progressively compress together theengaged tissues. The tissue-engaging faces 120A and 120B initiallycompress tissue toward the outer periphery of the faces 120A and 120Band then progressively clamp tissue in the a radially inward directionas previously described above with reference to FIGS. 2, 6A and 6B.

In FIG. 7B, the distal clamp assembly is moved longitudinally to aposition where the trocar 140 is locked into the proximal clampassembly. FIG. 7C shows the distal clamp assembly 115A movedlongitudinally to engage tissue which is caused by an initial movementof the actuator lever 155 from position A toward position B as shown inFIG. 1. As can be seen in FIG. 7C, the engagement face 100B is radiallysloped at angle X relative to the flat surface of the first face 120A.Thereafter, FIG. 7B corresponds to the actuator lever 155 being moved toposition B of FIG. 1 to thereby move the distal clamping face 120Btoward the electrode arrangement 125 under high compression. Thus, inFIG. 7D, it can be seen that the opposing tissue-engaging faces 120A and120B are parallel, with the face 120B flexed to angle Y, to compress theintestinal walls and engage the tissue against the electrode array 125.

Still referring to FIG. 7B, another step of a method of the inventionincludes clamping the tissue together until a predetermined tissuethickness is achieved. As described above, rotating the adjustment knobor grip 160 on the handle portion 104 is for fine control of the tissuethickness clamped between the proximal and distal clamp assemblies. Themechanical tissue thickness or gap indicator 170 in one variation can beused to determine the engaged tissue thickness.

In a variation, referring to FIGS. 7B-7C, a low level of electricalcurrent can be delivered to the engaged tissue with the bipolarelectrode array 125 or other dedicated electrodes as the clampingsurfaces engage and compress the tissue. The term low-level current inthis case means a level of electric current that does not heat orotherwise alter the structure of the tissue. The controller 195 then cancontemporaneously sense and monitor an electrical parameter of thelow-level current in the engaged tissue, for example impedance,capacitance and/or a phase angle of current in the engaged tissue. Thecontroller 195 can carry a look-up table to determine if the sensedelectrical parameter corresponds to a predetermined, known range of thatparticular electrical parameter which corresponds to a particularthickness of the engaged tissue. By this means, the controller 195 candetermine the thickness of the engaged tissue. Further, the controller195 can be adapted to multiplex current delivery among various electrodepairs and then determine if an average of the selected electricalparameter has been achieved to indicate the selected tissue thickness,or whether any tissue regions adjacent any energized electrode pair istoo thick or too thin to be thermally welded effectively. In onevariation, the low-level current can be pulsed, with power in the rangeof 2 W to 5 W and a pulse interval in the range of 1 to 25 millisecondsevery 50 to 250 milliseconds. When using the motor-driven closingfeature of the embodiment of FIG. 10, the initial closure rate of thecentral shaft can be from 5 cm/min to 50 cm/min and more often from 10cm/min to 25 cm/min. When the clamp faces are a selected distance apart,for example from 1 mm to 2 mm, then the closing speed changes for thefinal closure to the range of 2 to 4 mm/min. Contemporaneous with thefinal closing speed, the controller can sense the electrical parametersof the low-level current described above, and stop the closure when theselected electrical parameter is achieved. Typically, the clamp facescompress the engaged tissue to a thickness of 0.10 mm to 0.30 mm whereinone electrical parameter can be impedance in the range is 5-20 ohms.When closing the clamp faces manually with the device 100 of FIG. 1, theclosing can be continued with rotation of knob or grip 160 until thecontroller 195 signals that the selected electrical parameter has beenachieved.

A visual or aural signal can be provided to indicate to the physicianthat the engaged tissue is in a predetermined acceptable thicknessrange. In one variation, the controller 195 can include a lockingmechanism that prevents RF energy delivery if the tissue thickness isnot in the selected range.

Now referring to FIG. 7D, the physician then activates the RF source 190and controller 195 to multiplex RF energy delivery as described above tothereby weld the intestinal walls together. In one variation, RF energyis delivered over an interval during which the controller 195 calculatestissue impedance with the bi-polar electrode array and a controlleralgorithm is adapted to modulate and/or terminate RF energy deliveryafter a predetermined impedance parameter is reached which indicatesthat an effective tissue weld has been formed. Such impedance can becalculated continuously as RF energy is multiplexed between variouselectrodes pairs as the tissue is welded. In one variation, such apredetermined impedance parameter can consist of an average impedanceamong RF energy delivery to various electrode pairs. In anothervariation, the controller can terminate RF energy delivery to any firstpair of electrodes where a predetermined impedance parameter is reached,while delivering RF energy to any other electrode pairs, with RF energydelivery terminated at each such other pair when the predeterminedimpedance parameter is reached. It should be appreciated that otherelectrical parameters, such as capacitance, can be used in place of orin addition to an impedance parameter which are indicative of aneffective weld to control RF energy delivery.

In another variation, the system may include different types of sensorsfor determining whether the tissue weld is affected in the fluid type.For example, light transmission from an LED in the working end can betransmitted through the welded tissue and one or more locations in thesensor can sense transmitted light to determine whether the tissue weldis effective. In this variation, it can be understood that welded tissueas substantially different characteristics for light transmissiontherethrough than native tissue.

Following the welding of organ segments 400 a and 400 b, the physicianthen actuates the lever arm 155 from position B to position C (seeFIG. 1) to thereby advance the circular cutting blade 180 in the distaldirection to cut and remove tissue inward of the circular weld W (FIG.7E) thereby providing an opening between the lumens 402 a and 402 b ofthe two organ segments 400 a and 400 b. The excess tissue cut away bythe cutting blade 180 remains secured to the trocar 140 so that suchtissue is removed with the instrument.

Thereafter, the lever arm 155 is moved from position C back to positionA to thereby move apart the distal and proximal clamp assemblies 115Aand 115B so that tissue is no longer clamped by the working end 110.Then, as can be seen in FIG. 7E, the device 100 and working end 110 ismoved proximally and withdrawn from the organ lumens. As can be seen inFIG. 7E, the weld W then provides a fluid-tight connection between theorgan segments. When using the motor-driven device of FIG. 10, the motorcan be actuated in reverse to open the clamping assemblies.

In the embodiments described above, the electrode arrangement 125 iscarried in the proximal clamp assembly 115A, but it is also possible toposition the bi-polar electrode arrangement in the distal clampingassembly or with opposing polarity electrodes in both proximal anddistal clamp assemblies 115A and 115B with FIG. 11 illustrating avariation of distal clamp assembly 115B′. In such a configuration wherethe distal clamp assembly 115B′ carries such an electrode array 125″,electrical cabling from the RF source 190 to the distal clamp assembly115B′ is be carried in the interior of the trocar 140′ following itsconnection to the proximal clamp assembly 115A. The trocar 140′ cancarry electrical connectors 310 a and 310 b as shown in FIG. 11. As alsoshown in FIG. 11, the trocar 140′ can include an interior passageway 312extending therethrough with flow channels 314 extending to the electrodearray 125″ with the interior passageway 312 coupled to the negativepressure source 220 and the fluid source 225 to function as describedpreviously delivering fluid flows to them from electrode array 125″during and/or after the tissue welding step.

In any variation of clamping assemblies, energy delivery for tissuewelding can be provided by resistive heating elements, inductive heatingelements, ultrasound transducers, light energy emitters and the like.Further, a circular stapling mechanism can be provided in the clampingassemblies as is known in the art in combination with the thermalwelding mechanism described above.

Now referring to FIGS. 8 and 9, another component and related method ofthe invention is illustrated which is adapted for sensing the tension onthe organ segments 400 a and 400 b prior to the treatment stepsdescribed above. It can be understood that the organ segments 400 a and400 b must be mobilized or dissected away from connective tissue 415following a procedure which resects a portion of an intestine. Dependingon the length of intestine segment removed, it may be necessary todissect a significant amount of omentum and other connective tissues 415away from remaining segments 400 a and 400 b in order to eliminateunwanted axial tension on the organ segments after being connected. Inan open surgical procedure, it may not be difficult to mobilize theorgan segments manually so that there is no tension on the organsegments. However, in a laparoscopic procedure, it is difficult to sensewhether the organs are under such unwanted tension. If there remainsaxial tension on the connected organ segments, it could potentiallystress or damage the weld. In FIG. 8, it can be seen that pressuresensors 420 are positioned around an edge 422 of the proximal clampassembly 425A. Any number of such pressure sensors 420 can be provided,for example, from 1 to 10, with 4 such sensors shown in FIG. 8. Thesensors 420 can be any type of sensitive pressure sensor that is knownin the art such as electronic pressure sensor. In one variation, aplurality of force sensor resistors (FSRs) can be used to measuretension wherein such sensor are resistors that changes in resistivevalue in ohms in response to pressure on the resistive element. Suchsensors 420 are low cost and can be used in a combination around theperimeter 422 of the clamp assembly 425A to determine such tension.

In FIGS. 8 and 9, it can be seen the sensors 420 are connected to thecontroller 195 with electrical cabling 428 that can send electricalcurrent to the sensor to thereby allow the controller to monitorimpedance or another electrical parameter such as capacitance or phaseangle. In one variation, the controller 195 can average the pressuresensed among the plurality of sensors 420 and provide a visualindication on a screen on the controller 195 that indicates the axialtension on the organ segments 400 a and 400 b. In one variation, thecontroller 195 can prevent RF energy delivery for welding the organsegments if the tension exceeds a predetermined value. In thisvariation, the tension on the organ segments 400 a and 400 b can bemeasured and displayed on the controller 195 continuously during thestep of coupling the proximal and distal clamp assemblies together andthereafter closing together the clamp assemblies to approximate theproximal and distal segments 400 a and 400 b before RF energy isdelivered to weld the tissue.

While it should be appreciated that plurality of pressure sensors 420are shown in the proximal clamp assembly 425A, one or more pressuresensors also could be carried in the distal clamp assembly (see. FIG. 2)and coupled to the controller 195 through cabling in the trocar 140. Inanother variation, one or more sensors 420 in the interior of theproximal clamp assembly can be configured to measure tension on thetrocar after the proximal and distal clamp assemblies are lockedtogether.

FIG. 12 illustrates another variation of the proximal clamp assembly 450that is similar to that of FIG. 4 with an additional tissue coolingsubsystem 455 added to the component. In this variation, the coolingsubsystem 455 is provided to cool tissue in contact with the clampassembly 450 outwardly from the zone of weld tissue (See FIG. 7E). Itcan be important to prevent any thermal damage to the organ segmentsoutward from the weld. In one variation, subsystem 455 comprises one ormore a Peltier elements adapted to cool the entire proximal clampassembly 115A. In another variation, the subsystem 455 comprises orincludes a heat sink fabricated of any suitable materials that arehighly thermally conductive, for example, a conductive metal such ascopper or a similar highly conductive material. In another variation,the tissue cooling subsystem can comprise an active cooling system wherea cooling fluid flows through flow channels are provided, for example,with fluid flow provided by a motor driven pump carried in the handleportion. Alternatively, a cryogenic fluid can be released from acanister in the handle to flow through channels to cool the clampassembly. In other variations, the tissue cooling subsystem mechanismcan comprise or include a heat pipe extending into the handle as isknown in the art. All of the above cooling mechanisms also can beprovided in the distal clamp assembly 115B (see FIG. 2) with electricalconnections and/or flow channels in the trocar 140′ as shown in FIG. 11.

In general, a method corresponding to the invention shown in FIG. 13comprises (i) positioning first and second clamp components on opposingsides of tissue to be thermally welded, (ii) actuating the first andsecond clamp components thereby clamping and compressing the engagedtissue, (iii) delivering a low-power electrical current to the engagedtissue while actuating the clamp components and contemporaneouslysensing an electrical parameter which can be impedance, capacitanceand/or phase angle, (iv) determining the thickness of the engaged tissueby comparing the electrical parameter of the engaged tissue with alook-up table, (v) stopping actuation of the first and second clampcomponents when the sensed electrical parameter indicates a selectedthickness of the engaged tissue, and (vi) delivering RF energy to theengaged tissue to effect a tissue weld.

In general, another method corresponding to the invention shown in FIG.14 comprises (i) positioning first and second clamp components in firstand second organ segments, (ii) coupling the first and second clampcomponents with a central shaft, (iii) utilizing at least one sensormechanism in a clamp component to assess axial tension on the organsegments, (iii) if axial tension is acceptable, then delivering RFenergy to the engaged tissue to effect a circular tissue weld, (vi)optionally, utilizing a sensing mechanism to determine the character ofa tissue weld, and (vii) excising tissue inward from the circular weldto open the lumen between the organ segments.

FIG. 15 illustrates another optional component corresponding to theinvention which comprises a thin layer collagen member 452 which may beinserted between the organ segments 400 a and 400 b and thereby can beclamped between the engaged tissues. The use of such biocompatiblecollagen material can be used to fuse to the intestinal tissue andpotentially strengthen the thermal weld. In one variation, the collagencan be 100% native collagen together with impregnated antimicrobialsilver as is known in the art. Such antimicrobial silver can prevent agrowth and/or migration of bacteria outwardly from the lumen of theconnected segments. In one variation, the collagen member 452 can be ofthe type manufactured by Medline with a tradename of Puracol Plus AGCollagen Dressing.

FIG. 16 illustrates another variation of an electro surgical anastomosisdevice 500 which again has an elongate shaft 502 having a central axis505 which carries first and second clamping components 510A and 510Bwith first and second respective tissue-engaging faces 512A and 512Bconfigured for clamping together ends of first and second tubular organsegments as described previously. As can be seen in FIG. 16, circularbi-polar electrodes 520A and 520B arrangement are carried in therespective tissue-engaging faces 512A and 512B for thermally weldingtogether tissue of the first and second tubular organ segments. In thisvariation, a plurality of apertures 522 are carried in bothtissue-engaging faces 512A and 512B which communicate with a flowchannel 524 in the trocar or shaft portion 525 which is a component ofthe distal clamping component 510B as described previously. The flowchannel 524 in the shaft 525 further communicates with a remote fluidsource 530 for providing inflows through apertures 522 which is used tofacilitate release of tissue from the electrodes following energydelivery and the creation of the circular weld.

As an example, saline, sterile water or another similar biocompatiblefluid can be delivered to the treatment site contemporaneous withrelease of compression of the welded tissue. The fluid inflow can bepulsed or non-pulsed and can flow at any variable rate at the time anactuation mechanism is used to separate the tissue-engaging faces 512Aand 512B.

It should be appreciated that following energy delivery in the weldingof the tissue, there remains a possibility of tissue sticking to theelectrodes. Thus, the fluid inflow is provided from both sides of theclamping assembly to the engaged tissue to ensure that tissue does notstick to the electrodes. For this reason, the tissue-engaging faces maybe separated only slightly over a first-time interval ranging from onesecond to 30 seconds to infuse the treatment site with fluid.Thereafter, the rate of opening or separating the clamp components fromone another can be accomplished at a higher speed.

In one variation, a plurality of apertures 522 ranging from 4 to 100 ormore can be provided proximate each electrode arrangement in eachtissue-engaging face 512A and 512B to ensure against potential tissuesticking. The surgical device again as a bi-polar electrode arrangementthat comprises a plurality of spaced apart circular electrodes ofopposing polarities in each tissue-engaging face. A controller isadapted to sense at least one electrical parameter of current deliveryto tissue consisting of impedance, capacitance and/or phase angle tosense the thickness of engaged tissue when the first and second clampingcomponents engage tissue. Further, the controller is adapted to sense atleast one electrical parameter of current delivery (impedance,capacitance, phase angle) to sense an effective tissue weld to theterminate energy delivery. The controller 195 is further adapted toautomatically deliver the fluid inflows from the fluid source 530 aftersensing an effective tissue weld. Such fluid inflows can continue for aninterval ranging from 1 second to 60 seconds or more.

In one variation, the device further includes a motor drive configuredto move together and apart the first and second clamping components 510Aand 510B and the controller 195 can be adapted to actuate the motordrive to move apart the first and second clamping componentsautomatically following the termination of energy delivery andinitiation of the fluid inflows. In another variation, the controllercan be adapted to actuate the motor drive to move apart the first andsecond clamping components after a predetermined interval of actuatingfluid inflows from the fluid source 530, which may be from one second to20 seconds.

In a variation, the controller 195 is adapted slow or stop actuation ofthe motor drive to move apart the first and second clamping components510A and 510B when the controller senses resistance thereto cause bytissue adhering to the bi-polar electrode arrangement, wherein thecontroller can determine such resistance by monitoring motor voltagerequired to translate the clamping components 510A and 510B apart at apredetermined rate.

In one variation, the controller 195 is adapted to actuate a motor driveto move a circular cutting member 536 axially from either the first orsecond clamping component excise tissue inwardly of the first and secondtissue-engaging faces.

In another aspect of the invention, referring again to FIG. 16, thefirst and second clamping components 510A and 510B have first and secondrespective tissue-engaging faces 512A and 512B that are orientedrelative to the central axis 505 at an angle AA ranging from 30° to 85°.More often, the angle AA is 40° to 60°. As can be seen in FIG. 16,bi-polar electrodes are disposed in both the first and secondtissue-engaging faces 512A and 512B.

It should be appreciated the cutting mechanism can comprise a mechanicalblade 536 that is actuated manually or by a motor drive. Alternatively,the cutting mechanism can comprise an electrosurgical cutting elementthat again may be moved manually or by a motor drive.

Referring again to FIG. 16, in another aspect of the invention, thecentral shaft 525 of the second clamping component 510B which is adaptedfor lockable coupling to the first clamping component 510A includes aflow pathway 524 extending from the apertures 522 therein to a proximalend 542 of the central shaft 525. The proximal end of the central shaft525 includes a connector portion 544 for fluid-tight connection of theflow pathway to a flow channel in the elongate member that communicateswith the fluid source 530. O-rings 546 are provided to seal the spacearound the shaft 525 in bore 548.

Similarly, the central shaft 525 includes a connector 550 for couplingthe electrical conductors 552 in the second clamping component 510B witha cooperating electrical conductors (not shown) in the elongate memberwhich are connected to the RF source 190.

In another aspect of the invention, again referring to FIG. 16, at leastone of the first and second tissue-engaging faces 512A and 512B includesa plurality of insulative projecting elements 560 to prevent contact ofan electrode in the first face with an electrode in the second face asthe clamping components are approximated.

In general, a method of the invention comprises using an electrosurgicaldevice for connecting tubular organ segments so as to communicate withone another, and includes the steps of positioning the walls of a firsttubular organ segment around a proximal face of a first clamp componentof the device, positioning the walls of a second tubular organ segmentaround a distal face of a second clamp component of the device, movingtogether the first and second clamping components thereby clampingtogether walls of the first and second tubular organ segments,delivering electrosurgical energy between the proximal and distal facesof the clamping components to thereby provide a circular thermal weld inthe walls to connect the tubular organ segments, and providing a fluidinflow through apertures in both the proximal face and the distal faceto prevent tissue from adhering to the faces. The fluid inflows can bepulsed or non-pulsed.

In another variation of the method of the invention, a biocompatiblefluid can be sprayed or otherwise disposed on the electrodes prior toenergizing the electrodes to prevent tissue sticking. In one example,biocompatible silicone spray can be used prior to using the device.Other biocompatible fluids and sprays can be used as well for preventingtissue sticking.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A surgical device for end-to-end anastomosis andfor use with an energy source, the surgical device comprising: anelongate shaft carrying a first clamping component and a second clampingcomponent each respectively having a first tissue-engaging face and asecond tissue-engaging face, the first tissue-engaging face and thesecond tissue-engaging face configured for clamping together a first endof a first tubular organ segment and a second end of a second tubularorgan segment; a circular bi-polar electrode arrangement in at least oneof the first tissue-engaging face and the second tissue-engaging face,the circular bi-polar electrode arrangement configured to deliver energyfrom the energy source to thermally join or weld the first end to thesecond end; and at least one aperture in at least one of the firsttissue-engaging face and the second tissue-engaging face communicatingwith a flow channel in the shaft for providing inflows or outflow. 2.The surgical device of claim 1 further comprising a fluid sourceconfigured to provide fluid inflows through the flow channel andapertures to deliver fluid which facilitates release of joined tissuefrom the first tissue-engaging face and the second tissue-engaging face.3. The surgical device of claim 2 wherein the apertures are disposed inboth of the first tissue-engaging face and the second tissue-engagingface.
 4. The surgical device of claim 1 wherein the bi-polar electrodearrangement is carried in both of the first tissue-engaging face and thesecond tissue-engaging face.
 5. The surgical device of claim 2 whereinthe bi-polar electrode arrangement comprises a plurality of spaced apartcircular electrodes of opposing polarities.
 6. The surgical device ofclaim 2 wherein the energy supply comprises a controller and at leastone electrical source for delivering current and where the bi-polarelectrode arrangement is operatively connected to the controller and theat least one electrical source.
 7. The surgical device of claim 6wherein the controller is adapted to sense at least one electricalparameter of current delivery consisting of impedance, capacitanceand/or phase angle to sense the thickness of engaged tissue when thefirst and second clamping components engage tissue.
 8. The surgicaldevice of claim 6 wherein the controller is adapted to multiplex currentdelivery among various pairs of opposing polarity electrodes.
 9. Thesurgical device of claim 6 wherein the controller is adapted to modulatecurrent delivery to the bi-polar electrode arrangement in response tosignals from at least one temperature sensor.
 10. The surgical device ofclaim 6 wherein the controller is adapted to sense at least oneelectrical parameter of current delivery consisting of impedance,capacitance and/or phase angle to sense an effective tissue weld. 11.The surgical device of claim 10 wherein the controller is adapted toterminate current delivery when a sensed electrical parameter indicatesthe effective tissue weld.
 12. The surgical device of claim 10 whereinthe controller is adapted to deliver the fluid inflows from the fluidsource after sensing an effective tissue weld.
 13. The surgical deviceof claim 12 wherein the controller deliver the fluid inflows for aninterval ranging from 1 second to 60 seconds.
 14. The surgical device ofclaim 10 further comprising a motor drive configured to move at leastone of the first clamping component and the second clamping component.15. The surgical device of claim 14 wherein the controller is adapted toactuate the motor drive to move the first clamping component and/or thesecond clamping component at a variable rate.
 16. The surgical device ofclaim 15 wherein the controller is adapted to actuate the motor drive tomove the first clamping component and the second clamping component at afirst closing rate until the first clamping component and/or the secondclamping component are spaced apart by a selected distance followed by asecond closing rate to compress a tissue between the first clampingcomponent and the second clamping component to a thickness of less than0.5 mm.
 17. The surgical device of claim 16 wherein the controller stopsthe movement together of the first clamping component and/or the secondclamping component when the thickness of the engaged tissue is within apreselected range.
 18. The surgical device of claim 16 wherein thecontroller stops the movement together of the first clamping componentand/or the second clamping component controller when the controllersenses at least one electrical parameter indicates the thickness of thetissue is within a preselected range.
 19. The surgical device of claim14 wherein the controller is adapted to actuate the motor drive to moveapart the first clamping component and/or the second clamping componentafter the controller senses at least one electrical parameter indicatingan effective tissue weld.
 20. The surgical device of claim 14 whereinthe controller is adapted to actuate the motor drive to move apart thefirst clamping component and/or the second clamping component after apredetermined interval of delivering fluid inflows from the fluidsource.
 21. The surgical device of claim 14 wherein the controller isadapted to actuate the motor drive to move apart the first clampingcomponent and/or the second clamping component at variable speeds. 22.The surgical device of claim 14 wherein the controller is adapted slowor stop actuation of the motor drive to move apart the first clampingcomponent and/or the second clamping component when the controllersenses resistance to moving apart cause by tissue adhering to thebi-polar electrode arrangement.
 23. The surgical device of claim 22wherein the controller is adapted to sense resistance moving apart thefirst clamping component and/or the second clamping component by sensingmotor voltage.
 24. The surgical device of claim 14 wherein thecontroller is adapted to actuate the motor drive to move a circularcutting member axially from either the first clamping component and thesecond clamping component to excise tissue inwardly of the firsttissue-engaging face and the second tissue-engaging face.
 25. Thesurgical device of claim 24 wherein the controller is adapted to actuatethe motor drive to move the circular cutting member after the controllersenses at least one electrical parameter that indicates an effectivetissue weld.
 26. The surgical device of claim 1 wherein the firsttissue-engaging face and the second tissue-engaging face are orientedrelative to the central axis at an angle ranging from 30 to 85 degrees.27. A method of using an electrosurgical device for connecting tubularorgan segments so as to communicate with one another, comprising:positioning the walls of a first tubular organ segment around a proximalface of a first clamp component of the device; positioning the walls ofa second tubular organ segment around a distal face of a second clampcomponent of the device; moving together the first and second clampingcomponents thereby clamping together walls of the first and secondtubular organ segments; and delivering electrosurgical energy betweenthe proximal and distal faces of the clamping components to therebyprovide a circular thermal weld in the walls to connect the tubularorgan segments.
 28. The method of claim 27 further comprising providinga fluid inflow through apertures in both the proximal face and thedistal face to prevent tissue from adhering to the faces.
 29. The methodof claim 27 wherein the fluid inflow is pulsed.
 30. The method of claim27 wherein the fluid inflow is non-pulsed.
 31. The method of claim 27wherein moving together compresses the thickness of the walls to lessthan 1.0 mm, less than 0.5 mm, or less than 0.4 mm.
 32. The method ofclaim 27 wherein moving together is motor driven at more than one speed.33. The method of claim 27 wherein delivering includes multiplexingenergy delivery between a plurality of pairs of opposing polarityelectrodes in the proximal and distal faces.
 34. The method of claim 27further comprising removing steam from the energy delivery site througha flow pathway in the device.
 35. The method of claim 34 wherein thesteam escapes passively through the flow pathway.
 36. The method ofclaim 34 wherein the steam is extracted by a negative pressure source.37. The method of claim 27 further including excising tissue inwardly ofthe proximal and distal faces to thereby connect the lumens of the firstand second tubular organ segments.
 38. The method of claim 37 whereinexcising is accomplished with a sharp blade.
 39. The method of claim 37wherein excising is accomplished with an electrosurgical cuttingelement.
 40. A method of using an electrosurgical device for connectingtubular organ segments so as to communicate with one another,comprising: positioning the walls of a first tubular organ segmentaround an electrode-carrying face of a first clamp component, whereinthe face is coated with a biocompatible fluid for preventing tissueadherence thereto; positioning the walls of a second tubular organsegment around an electrode carrying face of a second clamp component,wherein the face is coated with a biocompatible fluid for preventingtissue adherence thereto; moving together the first and second clampingcomponents thereby clamping together walls of the first and secondtubular organ segments; and delivering electrosurgical energy betweenthe proximal and distal faces of the clamping components to therebyprovide a circular thermal weld in the walls to connect the tubularorgan segments.